Kornimate/medical-research-clean huggingface dataset:
efficacy of hypnotherapy in children with dental anxiety

Conditions: Dental Anxiety

Summary: dental anxiety is a common problem among the children. the aim of this study is to evaluate the efficacy of hypnotherapy in children with dental anxiety. the participants will be randomized in a 1:1 ratio to hypnotherapy or control group. the outcome measures will be modified children dental anxiety scale-faces version(mcdas(f)) and visual analogue scale(vas).


Eligibility criteria:
inclusion criteria: * initial mcdas(f) total score \> 19 * icdas ii (international caries detection and assessment score)= 5 for at least one tooth exclusion criteria: * presence of dental pain complaint * non-obtaining the informed consent form

Keywords: dental anxiety hypnotherapy pediatric dentistry
exploring radiotherapy of temporomandibular joint arthritis

Conditions: Arthritis of Temporomandibular Joint

Summary: with this pilot study, the acute side effects and potential pain relieve after radiotherapy (rt) of the temporomandibular joint (tmj) are prospectively recorded. for this purpose, the symptoms of the jaw joint arthrosis/arthritis are recorded using a symptom-oriented questionnaire and the numeric rating scale for pain assessment. furthermore, it is examined whether the irradiation is feasible.


Eligibility criteria:
inclusion criteria: * tmj arthritis * diagnosed by a surgeon for oral and maxillofacial surgery or a dentist exclusion criteria: * previous irradiation in the tmj area * age below 50 years
a trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of pf-04937319 in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of pf-04937319 following single escalating oral doses in adult subjects with type 2 diabetes mellitus (t2dm).

the purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of pf04937319 following single escalating oral doses in adult subjects with t2dm.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus who are taking stable doses of metformin only. subjects treated with a sulfonylurea (su) or a dipeptidyl peptidase-iv inhibitor (dpp-ivi) in combination with metformin may be eligible if washed off the su or dpp-ivi to metformin only for a minimum of 4 weeks before dosing. * male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (bmi) of 18.5 to 45.0 kg/m2 and c-peptide \>0.8 ng/ml. * screening and day -2 troponin i concentration \</=0.05 ng/ml as measured by the bayer centaur ultra assay. * hba1c \>/=7% and \ /=7% and \</=9.5%. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance \</=60 ml/min based on the cockcroft-gault equation, diabetic neuropathy complicated by neuropathic ulcers. * history of stroke, transient ischemic attack, or myocardial infarction within the past 6 months. additionally, history of coronary artery bypass graft or stent implantation, clinically significant peripheral vascular disease, or congestive heart failure (nyha classes ii-iv). furthermore, a current history of angina/unstable angina. also, 12 lead electrocardiogram (ecg) demonstrating qtc \>450 msec at screening, ecg findings suggestive of asymptomatic myocardial ischemia, or supine blood pressure \>/=160 mm hg (systolic) or \</=100 mm hg (diastolic). * one or more self reported episodes of hypoglycemia within the last 3 months, or two or more self reported episodes of hypoglycemia within the last 6 months. * screening or day -2 fasting (\>/=8 hours) blood glucose, \ /=270 mg/dl, confirmed by a single repeat if deemed necessary.

Keywords: phase 1 safety and tolerability pk pd type 2 diabetes mellitus t2dm
development of green mei products for the prevention of metabolic syndrome

Conditions: Hypertension

Summary: the aim of this study is to investigate the antihypertensive effects of mei-gin formula-4 (mgf-4) and mei-gin formula-7.

it's a randomized, and single-blind trial and was designed to evaluate the effects of mgfs (mgf-4 and mgf-4) on blood pressure. 50 participants with hypertension (systolic blood pressure between 130-179 mmhg or diastolic blood pressure between 85-109 mmhg) who did not accept any hypertension medication were randomized allocated to either mgf-4 or mgf-7 group. participants were instructed to take 4 capsules of mgf-4 or mgf-7 daily throughout the duration of the 8 weeks intervention study. after treatment, the change of the blood pressure and relative mechanism were analyzed.

Eligibility criteria:
inclusion criteria: * the age of the subject is 20 to 70 years old. * the subject is a patient with hypertension (sbp is between 130-179 mmhg, dbp is between 85-109mmhg, one of the two can be diagnosed), and there are no serious illnesses requiring hospitalization during the study period treatment. * no hypertension medication. * the subject can understand the test process described in the consent form and the possible potential risks and benefits, and able to sign the consent form. * the subjects shall observe diet control during the trial period. exclusion criteria: * subjects diagnosed with cancer and still under active treatment. * subjects diagnosed with heart disease and still under active treatment. * other drugs are used, whose pharmacological effects may affect blood pressure or may aggravate the effects of drugs. * subjects who have systemic infection and need systemic antibiotics.
detection of group a streptococcus (gas) in oral cavity

Conditions: Tonsillitis

Summary: the investigators intend to screen children who are suspected of having gas tonsillitis. from each child we will take a throat culture and saliva sample to screen for molecular evidence of gas.


Eligibility criteria:
inclusion criteria: * clinical evidence of gas tonsillitis * healthy, no chronic illness * not a gas carrier exclusion criteria: * gas carrier * active background disease

Keywords: gas in oral cavity
the effect of combining aprepitant with ondansetron in high-risk patients for postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: ponv (postoperative nausea and vomiting) is one of most common complications after general anesthesia. female sex, history of ponv, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing ponv. in consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing ponv. most of these patients use fentanyl based iv-pca. and it also causes ponv. so, we should prevent ponv in these patients by using multimodal or combination therapy. aprepitant is a nk1 receptor antagonist.and it is used to prevent chemotherapy induced nausea and vomiting. many studies using aprepitant to prevent ponv are in progress. in this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for ponv.


Eligibility criteria:
inclusion criteria: * patient undergoing laparoscopic gynecologic surgery. * patient who takes fentanyl based iv pca * asa class i-ii exclusion criteria: * allergy to aprepitant * take another antiemetics before surgery * decreased liver function * psychological disease * who cannot speak korean * take medicines that interacts with emend who do not agree to the study
role of markers in the progression of diabetes in obese patients

Conditions: Obese Patients

Summary: obese patients will be enrolled from 2006 to 2014. the progression of diabetes mellitus will be observed (if any). anthropometric and biochemical parameters will be evaluated.


Eligibility criteria:
inclusion criteria: * obesity (body mass index \>/= 30 kg/m2 * normal blood glucose (glycemia \< 100 mg/dl) exclusion criteria: * no exclusion criteria

Keywords: obesity diabetes mellitus
pupillometry guided remifentanil administration in pediatric anesthesia

Conditions: Anesthesia; Pain; Child

Summary: the aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. all patients are anesthetized with sevoflurane and remifentanil. in the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. in the other group, remifentanil infusion rate is guided according to hemodynamic data.


Eligibility criteria:
inclusion criteria: * children scheduled for a surgery lasting more than 90 minutes. exclusion criteria: * contraindication to sevoflurane, to remifentanil or to morphine. * peripheral or central nerve block during and after surgery. * ophthalmological disease. * peroperative position with no acess to the head. * chronic use of medication interfering with pupillary diameter. * ambulatory surgery

Keywords: intraoperative neurophysiological monitoring reflex, pupillary remifentanil
safety and preliminary efficacy study of nicotine gel to treat diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: the purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

this pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. the goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. the study will be carried out on a background of conventional wound therapy in patients with type ii diabetes mellitus. patients will be randomized to receive either study medication (atg002), vehicle gel, or standard-of-care.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type ii * single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease. exclusion criteria: * patients who use tobacco in any form or who are on nicotine replacement therapy

Keywords: diabetes foot ulcers nicotine gel wound healing
a pilot study, evaluating the efficacy of regulatory t-cell suppression by ontak in metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this study is designed to determine the duration of t reg suppression in patients with metastatic pancreatic cancer receiving ontak. the goal is to define the optimal time for future dendritic cell vaccine administration.

despite improved insight into the epidemiology and biology, pancreatic cancer remains a significant health problem as evidenced by the disappointing survival rates associated with advanced disease. because of its aggressive growth and early metastatic dissemination, only 20% of patients can be treated by surgery at the time of diagnosis. furthermore, the overall 5-year survival rate of stage iv disease is \< 5% \[1-3\] despite chemotherapy. with such a dismal outlook, it is obvious that novel treatment strategies are required. there is limited experience in the literature with the use of ontak in the treatment of metastatic pancreatic cancer. viehl, et al, demonstrated in a murine model of pancreatic cancer, that ontak combined with whole tumor vaccine led to a significantly increased t cell-dependent antitumor immune response, as well as an improved survival compared to controls. our group has an active trial at loyola evaluating the role of dendritic cell vaccine in patients with unresectable, not metastatic, pancreatic cancer. preliminary data suggests a correlation with time to progression and restoration of tregs following an initial decrease after the dc injection. the goal of the current proposal is to determine the time point at which the tregs reach the nadir within four weeks of ontak injection. when this is determined, we will eventually propose administering ontak followed by dc vaccine at the nadir treg time point for patients with unresectable pancreatic cancer

Eligibility criteria:
inclusion criteria: * male patients and nonpregnant, nonlactating female patient \> 18 years old * histologic diagnosis of pancreatic cancer with distant disease seen on ct or mri with no prior chemotherapy or radiotherapy for a least 4 weeks * karnofsky performance status equal to or greater than 70% * life expectancy of at least 3 months. * no uncontrolled pain * no symptoms of bowel obstruction * women with child bearing potential must agree to use adequate contraceptives. if she should become pregnant she needs to inform the treating physician * ability to give informed consent exclusion criteria: * positive serologic testing for hiv, aids, human t-cell lymphotrophic virus type 1, hepatitis b, or hepatitis c. * hemoglobin \<9g/dl; hematocrit \<27%; platelets \<100,000/ u/l without transfusion support * creatinine \> 1.8 mg/dl * serum albumin \< 2.0 mg/dl * ast \> 3x uln; alt \> 3x uln * bilirubin \> 1.8 * uncontrolled angina, arrhythmias, bronchospasm, hypertension, or hypercalcemia. * corticosteroid use within 28 days * chemotherapy or radiation within 28 days * bacteremia or other signs of active systemic infection * history of autoimmune disease

Keywords: denileukin diftitox metastatic pancreatic cancer ontak regulatory t-cell
the value of central venous-arterial carbon dioxide difference

Conditions: Jugular Veins; Radial Artery; Carbon Dioxide

Summary: by observing the changes of central venous-arterial partial pressure difference of carbon dioxide \[p (v-a) co2\] in liquid resuscitation during early escharectomy in patients with large-scale burns, we investigate the effect of p (v-a) co2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.

objective: by observing the changes of central venous-arterial partial pressure difference of carbon dioxide \[p (v-a) co2\] in liquid resuscitation during early escharectomy in patients with large-scale burns, we investigate the effect of p (v-a) co2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients. methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit（sicu）of guangzhou red cross hospital from january 2016 to december 2019. all patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (scvo2)\< 70% were excluded. patients were divided into the following groups according to the changing trend of pcv-aco2 between t base (before induction) and t 0h (after surgery) : group 1 (h-h) : pcv-aco2≥6mmhg between t base and t 0h. group 2 (l-h) : pcv-aco2\< 6mmhg at t base and≥6mmhg at t 0h; group 3 (h-l) : pcv-aco2≥6mmhg at t base and \< 6mmhg at t 0h. group 4( l-l) : pcv-aco2 \< 6mmhg between t base and t0h.postoperative basic physiological indicators such as heart rate（hr）, blood pressure, central venous pressure (cvp), cardiac output index (ci), pcv-aco2 and lactic acid were recorded at 0 and 18 hours after surgery. oxygen dynamic indicators such as oxygen delivery index (do2i), oxygen consumption index (vo2i), oxygen uptake rate (o2er) and so on were calculated. pearson correlation analysis was used to evaluate the correlation between pcv-aco2 and ci. the change of tissue perfusion and oxygenation with different levels of pcv-aco2 after fluid resuscitation were analyzed.

Eligibility criteria:
inclusion criteria: 1. asai-ii 2. new york heart association classification of cardiac function i-ii 3. estimated time of operation\<3h 4. the circulatory system of patients is stable after thrapy：cvp8～12 mmhg；map≥65 mmhg；urine volume\>0.5m1/kg/ h；scvo2：≥70％。 exclusion criteria: 1. anesthetic drug allergy or contraindication 2. patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.

Keywords: central venous-arterial carbon dioxide difference liquid resuscitation tissue perfusion and oxygenation
alk21-025: vivitrol's cost and treatment outcomes registry

Conditions: Opioid Dependence

Summary: the objective of the vivitrol registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.

the vivitrol registry is an observational, open-label, single-arm, multi-center registry of patients who have initiated treatment with vivitrol for prevention of relapse to opioid dependence, following opioid detoxification. the objectives of the vivitrol registry are: * to describe characteristics of patients receiving vivitrol for opioid dependence in real-world clinical practice. * to assess clinical, health economic, and health-related quality of life (hrqol) outcomes in a broad population of patients receiving vivitrol in real-world clinical practice. * to provide additional data to inform future research on vivitrol. patients 18 years of age or older who have been determined by their participating prescriber to be an appropriate candidate for vivitrol treatment may be offered enrollment into the registry. the decision to treat a patient with vivitrol will be made by the patient's participating prescriber independent of the registry. vivitrol will not be provided to patients enrolled in the registry in exchange for their participation; patients will receive commercially available vivitrol via a standard prescription that will be filled through standard commercial channels. patients will be observed while receiving vivitrol and for six months after they discontinue vivitrol use. the registry is non-interventional; it will neither direct the treatment plan for enrolled patients nor define the frequency of follow-up visits of each patient. a patient's participation in the registry will not influence or direct patient treatment procedures or follow-up care. it is expected that patients will be seen at least once per month during active vivitrol treatment to receive their monthly injection. during the standard monthly injection visits, patients will be asked to provide detailed health economics information using a variety of questionnaires, including the eq-5d and sf-12v2.

Eligibility criteria:
inclusion criteria: * patient is aged 18 years or older * patient is diagnosed with a current opioid dependence for which treatment with vivitrol is being initiated * patient has provided written informed consent * patient is willing and able to provide the information to be collected via the registry's interviews and questionnaires * patient expects to be available for ongoing registry participation exclusion criteria: * prior use of vivitrol

Keywords: opioid dependence vivitrol
efficacy and mechanisms of dapagliflozin in promoting kidney function and cardiovascular health in kidney transplant recipients

Conditions: Kidney Transplant; Complications; Vascular Diseases; Diabetes

Summary: long-term allograft function in kidney transplant recipients (ktrs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in ktrs and the most common cause of death with a functioning graft. sodium-glucose cotransporter 2 (sglt2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in ktrs are lacking. this clinical trial seeks to establish the efficacy and safety of dapagliflozin, a sglt2 inhibitor, for improving cardiovascular and kidney graft function in adult ktrs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.


Eligibility criteria:
inclusion criteria: * age 18-80 years * kidney transplant received 1 year prior to randomization * estimated glomerular filtration rate 30-90 ml/min/1.73m2 * urine albumin to creatinine ratio (acr) 30-5000 mg/g * pre-existing type 2 diabetes or post-transplant diabetes mellitus * blood pressure \<130/80 mm hg prior to randomization * able to provide informed consent * stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone * stable anti-hypertensive regimen for at least 1month prior to baseline * stable diabetes management for at least 3 months prior to baseline * stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable) * glucagon-like peptide-1 receptor agonist (glp-1ra) for at least 3 months prior to baseline (if applicable) exclusion criteria: * type 1 diabetes * anticipated life expectancy \<1 year * uncontrolled hypertension * hemoglobin a1c \>9% * body mass index \>40 kg/m2 * new york heart association class 3 or 4 heart failure symptoms, an ef ≤30%, or hospitalization for heart failure in the past 3 months * pregnancy, plans to become pregnant, or breastfeeding * current use of sodium glucose cotransporter-2 (sglt2) inhibitors * current urinary or urogenital infection * use of anticoagulants (contraindication to kidney biopsy) * magnetic resonance imaging (mri) contraindications * history of lower-limb amputation irrespective of etiology * known hypersensitivity to dapagliflozin
non-invasive determination of anemia in children with renal failure

Conditions: Renal Failure

Summary: anemia and inflammation are very common in patients with renal diseases. the most common procedure to detect anemia is to determine blood hemoglobin concentrations. the haemospect® is a portable device for non-invasive hemoglobin determination that works with a sensor that is applicable in infants and adults alike. the objective of this trial is to collect spectra with the non-invasive haemospect® device in children of different age groups with renal failure and different hemoglobin concentrations. in parallel, corresponding hemoglobin values shall be obtained invasively to form the basis for the development of an algorithm for the device. to determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are measured non-invasively with the haemospect®. various blood parameters for iron and inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron, white blood cell count and crp.


Eligibility criteria:
inclusion criteria: * all children in treatment for renal insufficiency in fundanier exclusion criteria: * none